AVET FDA Approval ANDA 205360

ANDA 205360

AVET

FDA Drug Application

Application #205360

Application Sponsors

ANDA 205360AVET

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL0.5MCG0DOXERCALCIFEROLDOXERCALCIFEROL
002CAPSULE;ORAL1MCG0DOXERCALCIFEROLDOXERCALCIFEROL
003CAPSULE;ORAL2.5MCG0DOXERCALCIFEROLDOXERCALCIFEROL

FDA Submissions

UNKNOWN; ORIG1AP2020-09-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AVET
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205360
            [companyName] => AVET
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"2.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-15
        )

)

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